Takepron Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions]

NCT02170207 | Completed Results

• 3 other identifiers: 254-012JapicCTI-142542JapicCTI-R160830
• Study Type: observational
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this survey is to evaluate the safety (that is, frequency of adverse events) and efficacy (that is, hemostatic effect, rate of rebleeding after confirmation of hemostasis) of administration of lansoprazole intravenous 30 milligram (mg) (Takepron Intravenous 30 mg ) to a large number of participants with acute stress ulcer or acute gastric mucosal lesion in daily medical practice.

Conditions

Acute Stress Ulcer and Acute Gastric Mucosal Lesions

Keywords

Pharmacological therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reporting One or More Adverse Drug Reactions

  Adverse drug reactions are defined as adverse events (AEs) which are in the investigator's opinion of causal relationship to the study treatment. AEs are defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

  Baseline up to Week 9

Secondary Outcomes (4)

• Percentage of Participants With Observed Hemostatic Effect

  Baseline up to Week 9

• Percentage of Participants With Confirmed Hemostatic Effect

  Baseline up to Week 9

• Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding During Treatment

  Baseline up to Week 9

• Percentage of Participants With Confirmed Hemostatic Effect Who Experienced Rebleeding After the Completion of Treatment

  Week 17 (8 weeks after the last dose of study drug)

Study Arms (1)

30 mg of lansoprazole

30 mg of lansoprazole is mixed in physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by drip infusion or dissolved in 20 mL of physiological saline (JP) or 5% glucose solution for injection (JP) and administered twice daily by direct slow intravenous injection.

Drug: Lansoprazole

Interventions

Lansoprazole DRUG

Lansoprazole 30 mg injection

Also known as: Takepron 30 mg Injection

30 mg of lansoprazole

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Acute stress ulcer and acute gastric mucosal lesions

You may qualify if:

• Participants with the following diseases for whom oral administration is not feasible:
• Acute stress ulcer, and acute gastric mucosal lesions (both of which should be accompanied by bleeding).

Sponsors & Collaborators

• Takeda: lead

MeSH Terms

Interventions

Lansoprazole; Injections

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Postmarketing Group Manager

  Takeda

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: January 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 8, 2016
• Results First Posted: March 8, 2016

Record last verified: 2016-02